NCT00924118

Brief Summary

The purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 25, 2017

Completed
Last Updated

May 14, 2018

Status Verified

April 1, 2018

Enrollment Period

6.9 years

First QC Date

June 17, 2009

Results QC Date

July 28, 2017

Last Update Submit

April 11, 2018

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionReperfusion injuryNitric oxide

Outcome Measures

Primary Outcomes (1)

  • Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.

    Measured as percentage of left ventricle

    4-5 days from enrollment

Secondary Outcomes (1)

  • Left Ventricular Infarct Size

    4-5 days following enrollment

Study Arms (2)

Sodium Nitrite

EXPERIMENTAL

Dose escalation of sodium nitrite.

Drug: Sodium Nitrite

Open Control

NO INTERVENTION

Standard therapy

Interventions

Sodium NitriteDRUG

Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.

Sodium Nitrite

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ST segment elevation myocardial infarction
  • Eligible for percutaneous coronary intervention

You may not qualify if:

  • Cardiogenic shock
  • Cardiac arrest
  • Prior infarct in the infarct related artery
  • Hemoglobinopathy, Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (3)

  • Gonzalez FM, Shiva S, Vincent PS, Ringwood LA, Hsu LY, Hon YY, Aletras AH, Cannon RO 3rd, Gladwin MT, Arai AE. Nitrite anion provides potent cytoprotective and antiapoptotic effects as adjunctive therapy to reperfusion for acute myocardial infarction. Circulation. 2008 Jun 10;117(23):2986-94. doi: 10.1161/CIRCULATIONAHA.107.748814. Epub 2008 Jun 2.

    PMID: 18519850BACKGROUND

  • Duranski MR, Greer JJ, Dejam A, Jaganmohan S, Hogg N, Langston W, Patel RP, Yet SF, Wang X, Kevil CG, Gladwin MT, Lefer DJ. Cytoprotective effects of nitrite during in vivo ischemia-reperfusion of the heart and liver. J Clin Invest. 2005 May;115(5):1232-40. doi: 10.1172/JCI22493. Epub 2005 Apr 14.

    PMID: 15841216BACKGROUND

  • Rassaf T, Flogel U, Drexhage C, Hendgen-Cotta U, Kelm M, Schrader J. Nitrite reductase function of deoxymyoglobin: oxygen sensor and regulator of cardiac energetics and function. Circ Res. 2007 Jun 22;100(12):1749-54. doi: 10.1161/CIRCRESAHA.107.152488. Epub 2007 May 10.

    PMID: 17495223BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium Compounds

Limitations and Caveats

The primary and secondary outcomes of this study were limited by too few subjects undergoing these studies.

Results Point of Contact

Title
Steven P. Schulman, MD
Organization
Johns Hopkins Hospital
sschulma@jhmi.edu
4109557378

Study Officials

  • Steven P Schulman, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 14, 2018

Results First Posted

September 25, 2017

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)